Planning for the Novel H1N1 Influenza Vaccination Campaign Debra Blog, MD, MPH, Director Bureau of Immunization New York State Department of Health October 7, 2009 1
Influenza Prevention Influenza vaccination is the primary means to prevent influenza, its transmission, and associated complications 2
2009 H1N1 Vaccine Basic information on H1N1 Vaccine Target Groups Manufacturing Availability Vaccine Distribution Allocation Finance Dispensing Clinical Management Workforce Safety How to Register for Vaccine Seasonal influenza and Pneumococcal Vaccine
Target Groups Advisory Committee on Immunization Practices (ACIP) met July 29 th and set priority groups. Phased Vaccination Initial Target Groups: Pregnant Women Household and caregiver contacts of children younger than 6 months of age Healthcare and emergency services personnel Persons from 6 months through 24 years of age Persons aged 25 through 64 years of age who have medical conditions that are associated with a higher risk of influenza complications 4
Target Groups Prioritization within these target groups might be necessary if initial vaccine availability is insufficient to meet demand: Pregnant women Household and caregiver contacts of children younger than 6 months of age Healthcare and emergency services personnel with direct patient contact Children 6 months of age through 4 years Children 5 years of age through 18 years who have medical conditions that are associated with a higher risk of influenza complications 5
Target Groups Once demand from initial target groups is met: Provide vaccine to all adults aged 25 through 64 years of age Vaccination can be offered to persons 65 years of age and older once demand is being met among younger groups 6
Target Groups (Continued) Priority Group Seasonal Vaccine Recommended Initial Target Groups for H1N1 Vaccine Workers in health care settings Adults age 25-64 years with underlying medical conditions** + + + + Pregnant women + + Household contacts and caregivers for children younger than 6 months of age Adults age 65 years and older Young adults less than 25 years of age Anyone who wishes to be vaccinated + + + + + 7
Vaccine Manufacturing Vaccine is being manufactured Novel H1N1 vaccine is being procured by the U.S. government at no cost to us. The 5 manufacturers of currently licensed seasonal influenza vaccines are in the process of making H1N1 vaccine. It will be available in both the inactivated (the shot) and live, attenuated (nasal spray) forms 8
Vaccine Manufacturing (Continued) It will be available mostly in multi-dose vials (with thimerosal)-about 50% With lesser amounts of single-dose syringes (thimerosal-free) and nasal spray vaccine 9
Manufacturing Continued New information says that one dose is enough for those 10 years and up. For those 9 years and younger 2 doses will be needed. 4/5 have been licensed: Not GSK It is very unlikely that any of the vaccine available in the US still will contain an adjuvant, an immune booster. Clinical trials are being conducted to determine response, safety, number of doses required, any age exceptions. 10
Clinical Trials Some results were recently published in the New England Journal of Medicine Key Points in the editorial by Dr. Kathleen Neuzil: One study shows that a single dose of vaccine containing the usual 15 μg of antigen is immunogenic in a high proportion of healthy young and middle-aged adults. 11
Clinical Trials (Continued) Another study looked at vaccine containing an adjuvant and one or two doses of an adjuvanted influenza vaccine containing 7.5 μg of HA (50% of the standard dose), administered on various schedules, elicited robust antibody titers. Don t know yet if this will also be the case for children or adults who have underlying immune suppression or high-risk conditions. 12
Clinical Trials (Continued) From seasonal vaccine we know that the immune responses in older children, pregnant women, and immunocompetent adults with chronic conditions are roughly similar to those of healthy nonpregnant adults. Younger children generally have inferior responses to inactivated vaccines, as compared with healthy adults, and children under 9 years of age are recommended to receive two doses the first year that they receive influenza vaccine. 13
Clinical Trials-Safety Both vaccines tested have generally acceptable side-effect and adverse-event profiles. Pain or tenderness at the injection site were the most common adverse event observed. The local reactions seen with the adjuvanted vaccines were moderately higher than those generally seen with nonadjuvanted vaccines. Any association of uncommon adverse events cannot be ascertained in studies of this size. 14
Clinical Trails-Safety (Continued) The manufacturing process for these vaccines is identical to that used for seasonal vaccines, which have a strong record of safety. Additional studies are ongoing that will address the immunogenicity of live-attenuated vaccines, and additional inactivated vaccines, in various age groups and on various schedules and in combination with seasonal influenza vaccines. 15
H1N1 Vaccine Availability Availability is dependent on multiple factors including: Virus growth Speed of regulatory review Production capacity Has been released before clinical studies are completed Doses are being shipped this week. 16
H1N1 Vaccine Amounts Initial planning scenarios (national amounts) Bolus of 40, 80, or 160 million doses over 4 weeks Weekly amounts of 10, 20, or 30 million doses per week after the bolus period Likely to be about 40-50 million doses initially and then 20 million doses per week Not working out this way Amounts vary by week Allocations are not know for sure until the amounts are announced each day. 17
Distribution Centralized distribution will be available from CDC/McKesson Specialties About 90,000 + drop sites in the nation = about 3,600 in NYS, these are called ship-to-sites The New York State Department of Health (NYSDOH) will control distribution in cooperation with the local health departments Hybrid between central distribution, state distribution, LHD distribution 18
Vaccine Purchase and Allocation The H1N1 vaccine will be publicly funded and controlled. It is being purchased by the U.S. government. It will be made available at no cost. Syringes, needles, sharps containers, and alcohol swabs will also be provided at no cost. Vaccine will be allocated to states based on population. 19
Vaccine Dispensing Will need to partner with the private sector to deliver vaccine Possible settings for vaccination: Local health department clinics Schools Colleges and Universities Provider offices (primary care, Peds, OB/GYN, Family Medicine, Internal Medicine) Community health centers Pharmacies Health care facilities (hospitals, outpatient settings, etc.) Certain occupational settings Through mass or community vaccinators 20
Financing Vaccine Administration America s Health Insurance Plans (AHIP), New York State Insurance Department (SID) and NYSDOH urge that the administration fee be covered by all insurance plans. AHIP: public health planners can make the assumption that health plans will provide reimbursement for the administration of a novel (A) H1N1 vaccine to their members by private sector providers in both traditional settings e.g., doctor s office, ambulatory clinics, health care facilities, and in non-traditional settings, where contracts with insurers have been established. -CDC website Will be covered by Medicare and Medicaid A planning assumption is that the administration fee will be covered by insurance-letter, Governor s statement It is not clear yet how the administration fee for those who are uninsured will be covered Federal funds have been awarded to states to assist with the vaccination campaign 21
Clinical Management Planning for a number of vaccine related clinical tools: Fact sheets for medical providers Fact sheets for patients Took kit for medical practices Tool kit for OB/GYNs-ACOG Tool kit for schools Q and As Planning for training/education Vaccination Handling and Storage Target groups, e.g. daycare centers Webinars
Workforce Partners Working with medical professional societies Volunteers Students of all sorts Looking at liability issues-prep Act protects vaccinators, Q and A is available on the NYSDOH website Looking at scope of practice issues Mass vaccinators
Vaccine Safety and Effectiveness There will be ongoing safety and effectiveness monitoring throughout the vaccine campaign. Will use existing safety monitoring systems: Vaccine Adverse Event Reporting System (VAERS), cosponsored by the CDC and the FDA, a passive system that collected reports on adverse events Vaccine Safety Datalink (VSD), a network of managed care organizations, to test signals from VAERS Also, active surveillance for Guillain Barre Syndrome (GBS) incidence will occur Effectiveness studies will be conducted throughout the campaign. 24
How to Register to Receive H1N1 Vaccine All sites that wish to receive H1N1 vaccine must pre-register at: https://hcsteamwork1.health.state.ny.us/pub/ Requirements for registration differ for pediatric (patients less than 19 years) and adult providers. Some sites such as colleges and Universities and family practice sites are both For All Providers: Part of the registration process - sign a provider agreement that has been supplied by the Federal government, with some NYS additions If you already registered must go back and sign the provider agreement By signing the agreement you agree to appropriately store and handle the vaccine, to give vaccines only to the CDC targeted groups, and to report vaccine usage. 25
How to Register (Continued) Pediatric Providers have 2 other steps if NOT already active in the New York State Immunization Information System (NYSIIS), also know as the immunization registry 1. Establish a NYSDOH Health Commerce System (HCS) account 2. Establish access in NYSIIS All medical providers can use NYSIIS 26
Health Commerce System Account Health Commerce System (HCS) (also referred to as the Health Provider Network or the HPN) is a secure webbased system designed by the NYSDOH specifically for electronically exchanging health-related data and information between health care providers and NYSDOH. Note: this is the same account that physicians use to order prescription pads and update their Physician Profile; all physicians should have an account. Completing the on-line HCS application request form will bring the user to the H1N1 vaccine pre-registration form and the HCS application information will pre-populate appropriate fields to expedite the H1N1 vaccine preregistration process. 27
NYSIIS NYSIIS participation is required by NYS law for providers who immunize children less than 19 years of age. Participating in training establishes a NYSIIS user account. 47 electronic health record/billing vendors are approved to automatically upload immunization information into NYSIIS. The website above provides additional information on an online orientation to NYSIIS and training opportunities for new users. 28
More NYSIIS NYSIIS provides a number of advantages for providers during this campaign 1) automatically generates the federally mandated weekly vaccine usage reports, 2) monitors vaccine inventory to enable prompt reordering, 3) generates reminder lists and letters for the second influenza vaccine dose, if required, 4) provides a legal record of the vaccination, 5) enables correct ascertainment of prior influenza vaccine history if patients receive some influenza vaccine doses (seasonal and/or monovalent H1N1) at other provider sites, and 6) enables NYSDOH to more closely monitor possible vaccine adverse events. 29
Reporting H1N1 Vaccine Usage For those who are vaccinated and are 19 years of age and older, NYSDOH will be providing a variety of options to report. You will only have to report the number of doses administered by age groups The number of doses wasted or expired Weekly For those who are vaccinated and are 18 years of age or younger, the vaccinations must be entered into NYSIIS The required reports can be generated from NYSIIS so you do not need to report! 30
Receiving Vaccine Registering does not guarantee receipt of vaccine Not everyone can receive vaccine at the same time Vaccine will be ordered county by county 31
Ordering Vaccine The Vaccine Call Center will take orders 5 days a week. The NYSDOH will place orders twice per week At first vaccine will be allocated based on supply. Later will be like the regular ordering procedure for VFC vaccine and orders will be taken on a regular basis First doses were ordered 9/30 Will ship out this week First to receive vaccine were hospitals, local health departments, and Federally Qualified Health Centers First doses were LAIV only
Uses of Seasonal Flu This Fall Use vaccine as soon as it is available Protection does seem to exist throughout the year, even when given early About 118 million doses available, revised down to 113-115 million 15 million doses available by mid-august 40 million by 9/1 More than 90% will be shipped by 11/1 In each will be p-free and infant-toddler formulations 33
Seasonal Influenza Vaccine Supply CDC s message: All manufacturers are on target to make the expected 113-115 million doses expected. Vaccine became available early There is already a significant amount of vaccine in the market Vaccine continues to be shipped Due to low-yielding B strain and expedited production of H1N1, seasonal vaccine delivery will be extended 34
Seasonal Vaccine Supply (Continued) Most doses will be out by the end of November instead of the end of October This is still more than has even been used in any influenza season This is still earlier than it has gotten out in any other season Still time to vaccinate before usual peak in February Also considerable double booking Is there more demand? 35
Pneumococcal Vaccine Bacterial pneumonia is the most frequent complication of influenza disease. It is important to immunize all who are indicated to receive pneumococcal vaccine. Important to cover this vaccine for all who are indicated to receive it.
Seasonal and Novel H1N1 Influenza Vaccines Disease from both viruses will overlap Vaccination for both will overlap Some children (those under 9 being vaccinated for the first time) will need 4 vaccines: 2 seasonal and 2 H1N1 Adults will need 2 vaccines: 1 seasonal and 1 H1N1 Concerns about only one flu vaccine covered by insurance per 12 month period-being addressed Not appropriate for seasonal or H1N1 vaccine
Seasonal and Novel H1N1 Influenza Vaccines Can give the two injectable types at the same time Can give combos of injectable and nasal at the same time Can t give the two nasal vaccines at the same time. Interval between doses is 28 days. May be shorter. Interval between injectable seasonal and H1N1 vaccine can be any length of time.
Planning for H1N1 This Fall Stay tuned for more information Vaccine Call Center: 1-800-KID-SHOT Hotline for the public: 1-800-818-1987 39
Questions? 40